Gazette.govt.nzPursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
| Product: | Sunitinib Sandoz |
| Active Ingredient: | Sunitinib 12.5mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturers: | Remedica Limited, Limassol Cyprus Pharmacare Premium Limited, Birzebbugia, Malta |
| Product: | Sunitinib Sandoz |
| Active Ingredient: | Sunitinib 25mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturers: | Remedica Limited, Limassol, Cyprus Pharmacare Premium Limited, Birzebbugia, Malta |
| Product: | Sunitinib Sandoz |
| Active Ingredient: | Sunitinib 37.5mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturers: | Remedica Limited, Limassol, Cyprus Pharmacare Premium Limited, Birzebbugia, Malta |
| Product: | Sunitinib Sandoz |
| Active Ingredient: | Sunitinib 50mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturers: | Remedica Limited, Limassol, Cyprus Pharmacare Premium Limited, Birzebbugia, Malta |
| Product: | Tacrolimus Sandoz |
| Active Ingredient: | Tacrolimus monohydrate 0.511mg equivalent to tacrolimus 0.5mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Sandoz Private Limited, Navi Mumbai, India |
| Product: | Tacrolimus Sandoz |
| Active Ingredient: | Tacrolimus monohydrate 0.767mg equivalent to tacrolimus 0.75mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Sandoz Private Limited, Navi Mumbai, India |
| Product: | Tacrolimus Sandoz |
| Active Ingredient: | Tacrolimus monohydrate 1.022mg equivalent to tacrolimus 1mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Sandoz Private Limited, Navi Mumbai, India |
| Product: | Tacrolimus Sandoz |
| Active Ingredient: | Tacrolimus monohydrate 2.044mg equivalent to tacrolimus 2mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Sandoz Private Limited, Navi Mumbai, India |
| Product: | Tacrolimus Sandoz |
| Active Ingredient: | Tacrolimus monohydrate 5.11mg equivalent to tacrolimus 5mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Sandoz Private Limited, Navi Mumbai, India |
Dated this 30th day of June 2023.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).